COVID-19 herbal remedy: More hurdles before final approval
As Coronvirus disease (COVID-19) cases continue to soar, there seems to be hope for herbal remedies as the Federal Government, through the Presidential Task Force (PTF) has approved three herbal drugs for clinical trials, in the hope that soon, a homegrown drug would emerge.
Although these herbs have passed the approval for clinical trial stage, there are still hurdles ahead before they are finally approved as COVID-19 drugs, and registered with the National Agency for Food, Drug Administration and Control (NAFDAC). And the trial may still take months before conclusion.
Shedding light on the process, an epidemiologist and public health expert, Prof. Tanimola Akande said: “To ascertain the safety of these drugs, clinical trials are conducted. The trials are usually long and varied with the drug being investigated.
Clinical trials will usually start with the use of animals to see the efficacy and safety of the drug. Occasionally, depending on the countries’ regulations, this step may be skipped. The new drug is then tried on patients,” he said.
The next stage, according to him is the human testing of experimental drugs, which is typically conducted in four phases. “The first phase studies assess the safety of a drug. This initial phase of testing may take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans, including how it is absorbed, metabolised, and excreted. This phase also investigates the side effects that occur as dosage levels are increased.
“Phase Two studies tests the efficacy of a drug, and this phase of testing can last from several months to two years, and involves up to several hundred patients. Most Phase Two studies are randomised trials, where one group of patients receives the experimental drug, while a second ‘controlled’ group receives a standard treatment, or placebo. Often, these studies are “blinded,” which means that neither the patients, nor the researchers know who has received the experimental drug.
“Phase Three studies involve randomised and blind testing in large number of patients. This large-scale testing, which usually last months, and even years depending on the nature of the disease, and mode of action of the drugs provides understanding of the effectiveness of the drug, the benefits and the range of possible side effects. Once Phase Three is completed and successful, a pharmaceutical company, after approval from appropriate authorities, can market the drug.
“The Phase Four further monitors the effect of the drug, and its adverse effects over years. If the drug is proven to be effective and safe, then it is registered with appropriate authorities and produced in large quantities for marketing and use,” he explained.
On why the Federal Government failed to show much interest in herbal medicine as possible cure for COVID-19 until Madagascar’s COVID-Organics arrived, he said: “The FMoH has always shown interest in herbal medicine even before now.
The challenge is the readiness to take these preparations through clinical trials to ensure their safety and efficacy. Drug development and use in the scientific world is not what you just wake up and make claims. Such claims must be verified. More than 50 claims were made about herbal drugs for treatment of COVID-19, but only a few were ready to allow verification of the efficacy and safety. The interest in developing herbal drugs had been there before now, but the Madagascar medicine is only bringing it more to public attention. The World Health Organisation (WHO) has also cautioned on the use of the Madagascar herbal medicine without verification through appropriate scientific process.
Explaining more about herbal drugs and orthodox practise in the country, he said: “The Nigerian health system allows the use of both orthodox and herbal medicine, even though the later is much patronised and developed in Nigeria. Herbal medicine predates orthodox medicine in Nigeria, but sadly it has not grown at the same pace with orthodox medicine.
“Some drugs that are seen as orthodox medicine are derived from herbs, and some countries have done quite well in promoting herbal medicine by subjecting their herbal drugs to research and clinical trials. This is not the case in Nigeria. There is so much ‘secrecy’ on the contents and dosage of these herbal preparations, and the readiness to subject them to rigorous clinical trials is low. Nigeria established the Nigeria Natural Medicine Development Agency in 1997, housed it in the Ministry of Science and Technology with a mandate to research, develop, document, preserve, conserve and promote natural medicine, which are mainly herbs. NAFDAC is also involved with some other agencies in coming up with herbal preparations that can be useful in our health system, but the pace of developing these herbal medicines such that they will be scientifically acceptable for use in our health system is low.
“Unfortunately, there are so many claims about efficacy of certain herbal products that may not be true, and those behind them are not keen about taking such preparations through rigorous clinical trials. Some of these herbal preparations in Nigeria are known to cause a lot of damage to organs in the body. Doctors see such cases frequently in the hospitals. There is no doubt that a number of the herbal preparations can be developed through research, and put to good use in our health system. Nigeria has a health policy that also promotes development and the use of natural medicines.
“In addition to the above, it should be noted that in Nigeria, WHO had supported the development of the traditional medicine policy, and have assisted the Department of Food and Drug Services, as well as built capacity of the staff on traditional, complementary and alternative medicines. For the COVID-19 pandemic, the FMoH and the PTF have also given the go ahead for clinical trials of some herbal preparations that may be effective in the treatment of the virus,” the epidemiologist stated.
“Finally, there is need for herbal practitioners to subject their claims to scientific verifications, he aid, adding, “the herbal medicine resources in Nigeria are enormous. These resources need to be tapped. Herbal practitioners need to embrace the importance of subjecting their claims to scientific verification and also be transparent in the whole process. Government agencies saddled with the responsibility of developing herbal medicine need to be more active and collaborate with relevant stakeholders, including pharmacy departments in our universities, as well pharmaceutical companies. Pharmaceutical companies need to invest in the research and development of herbal preparations with proven safety and efficacy.”